FDA clearance of HIFU met with enthusiasm, questions

The Sonablate 450, SonaCare Medical’s high-intensity focused ultrasound (HIFU) device, has received FDA clearance for prostate tissue ablation.

Read: Fusion biopsy increases detection of high-grade PCa

The move clears the way for the company to market the Sonablate for that indication, according to a SonaCare press release.

The approval has been greeted with enthusiasm from trial researchers and optimism from experts in the field, although one thought leader says several questions remain about the treatment.

"I believe that we are at a pivotal point in prostate care,” said Sonablate trial investigator Michael Koch, MD, of Indiana University, Indianapolis, in the press release. “Simultaneous advances in imaging, fusion technologies, and now more focused therapies are going to allow us to precisely diagnose prostate conditions, and ablate these targeted areas rather than perform whole-gland prostate surgery, which carries a significant burden on quality of life. HIFU will become the workhorse of subtotal prostate therapy.”

Another trial researcher, Herbert Lepor, MD, of New York University School of Medicine, New York, said the anticipation is that ablative urologic surgeons in the U.S. will embrace the technology.

“HIFU offers the opportunity for the precise delivery of ablative energy to the prostate. Thus, it can be adapted to whole gland or focal gland ablation," Dr. Lepor said.

Sonablate is the first high-intensity therapeutic ultrasound device to receive FDA regulatory authorization for prostate tissue ablation, according to SonaCare. It has been authorized for use for this indication in more than 49 other countries. SonaCare said it expects to begin U.S. distribution this October.

Next: Dr. Thrasher cautiously optimistic

Urology Times Editorial Consultant J. Brantley Thrasher, MD, of the University of Kansas Medical Center, Kansas City, told Urology Times that he is cautiously optimistic.

“This is a treatment for localized prostate cancer and, for the most part, it is an ablative therapy similar to cryotherapy in that most of the studies are small and in low-grade prostate cancers,” said Dr. Thrasher. “The problem that we face with HIFU is that we do not have randomized controlled trials comparing this treatment to standard therapies, such as surgery and XRT [external beam radiation therapy].”

Also see: Focal, whole-gland cryo yield similar cancer control

HIFU may very well find a place in urology, according to Dr. Thrasher. But questions remain, including which localized prostate cancer patients are best for this treatment, “especially when we consider that many prostates that we remove for cancer have three to five tumors in the prostate,” Dr. Thrasher said.

Other questions: How do the oncologic and functional outcomes compare to standard treatments, and how do cost and complication rates compare?

“Before I get too excited about the FDA’s decision, I would need to have several of these questions answered,” Dr. Thrasher said.

The U.S. availability of the treatment will be convenient for patients, says Urology Times Editorial Council member Leonard G. Gomella, MD, of Thomas Jefferson University, Philadelphia.

"After many years of this technology being available to patients outside of the United States, it is encouraging that patients in the U.S. may be offered this minimally invasive technology without travelling abroad or participating in a clinical trial. While the device can ablate both benign and malignant prostate tissue, it is clear that the utility will be in those men with local prostate cancer," Dr. Gomella told Urology Times.

Next: Divided reaction on Twitter

Urologists on Twitter seem divided on the FDA clearance. Benjamin J. Davies, MD, of the University of Pittsburgh School of Medicine, tweeted, “Somebody get me a positive quote from a non-biased (financial intertwined person) on HIFU for prostate cancer.”

Stephen Scionti, MD, director of Scionti Prostate and Men’s Health in Sarasota, FL, tweeted: “The FDA has approved #HIFU via the de novo 510 process for #prostate ablation. Great news for American men!!” Dr. Scionti advertises on his website that he "has been recognized as a world leader in the HIFU arena and is treating patients at The International HIFU Prostate Cancer Center in George Town, Grand Cayman."